Medtronic ITB TherapySM Dosing by Diagnosis

Important Safety Information on ITB Therapy ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long-term intrathecal baclofen therapy. Important Safety Information for ITB Therapy: Intrathecal Baclofen Withdrawal: Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.

Important Safety Information on ITB Therapy continued The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Pump system component failures leading to pump stall, or dosing/programming errors may result in clinically significant overdose or underdose. Acute massive overdose may result in coma and may be life threatening. The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space, catheter break/cut, and implant site infection including meningitis. Electromagnetic interference (EMI) and Magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate. Please refer to the full prescribing information and system information for details or call Medtronic at (800) 328-0810.

Expert Speaker Roy Adair, M.D. Board certified – PM&R, SCIM and EDX Chair & Medical Director Advocate Christ Medical Center, Oak Lawn, IL 13 years experience managing ITB Therapy patients Currently manages over 100 patients Primarily manages adult patients (90+%)

Agenda Dosing differences by patient population Minimum and maximum dosing by diagnosis - Red flags Clinical guideposts for optimal dosing and differences in responses Benefits of proven performance and long-term intrathecal therapy experience Questions and Answers

Value of tracking dosing trends by the different diagnoses Allows for better planning and patient discussions prior to implant. predicting on average how often refills might be Allows for better prediction of how long it may take to titrate to a therapeutic dose   Allows for more appropriate and prompt attention to the need of diagnostic evaluation of a pump/catheter system if the dose exceeds that expected (on average) for that diagnosis

My practice average doses by indication 50 40 Number of Patients 30 20 10

My practice dosing ranges by indication

Benefits of tracking the dosing by diagnosis and tips for others Part of tracking also MUST include the alarm dates for safety. Track your own rate of complications of all types. Allows for proactive corrective action to minimize the complications and therapy disruption For example, infection rate increase may lead to reevaluation of the OR procedures. If you don't track the rate, you're working in the dark. I've diagnosed catheter malfunction numerous times on patients referred to me for additional evaluation, and the tip off was the dose, the response and the diagnosis. Tracking tool will allow you to better market your program to referral sources, IF you know where your patients come from. A dashboard summary which a tracking tool should provide will be very useful when working with the administrative counterparts responsible for your area.

My referral sources as captured through tracking

Overview of my information captured through tracking

Potential Risks of ITB Therapy Abrupt discontinuation can result in high fever, altered mental status, returned spasticity, and muscle rigidity, and in rare cases, fatality It is important to keep the pump filled with medication by attending regularly scheduled refill appointments and to understand the early symptoms of baclofen withdrawal The most common side effects include loose muscles, drowsiness, upset stomach, nausea/vomiting, headache, and dizziness Overdose, although rare, could lead to respiratory depression, seizures, loss of consciousness, reversible coma, and in extreme cases, may be life-threatening Once the infusion system is implanted, device complications may occur which may require surgery to resolve Possible complications include the catheter or pump moving within the body or wearing through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in under-dose or no baclofen infusion. The pump could stop because the battery has run out or because of component failure. Complications may cause overdose or under-dose of intrathecal baclofen PHYSICIAN: Surgical complications are possible and include infection, spinal fluid leak and headache. You should not undergo the implant procedure if you have an active infection at the time of implant. As with all medications, there are some potential risks associated with ITB Therapy. It is important to follow your doctor’s instruction closely because a sudden stop of ITB Therapy can result in serious illness such as high fever, changed mental status, muscle rigidity, and in rare cases, multiple organ-system failure and death. Because of these risks, it is important to keep your pump filled with medication by attending regularly scheduled refill appointments and to understand the early symptoms of baclofen withdrawal. Side effects associated with ITB Therapy usually are temporary and can be managed by adjusting the dosage of intrathecal baclofen (the drug contained in the pump). The most common side effects include loose muscles, drowsiness, upset stomach, nausea/vomiting, headache, and dizziness. Overdose, although rare, could lead to respiratory depression, seizures, loss of consciousness, reversible coma, and in extreme cases, may be life-threatening. Please also refer to the important safety information at the end of this presentation.

Question and Answer Session

FOR FULL PRESCRIBING INFORMATION Visit: http://professional.medtronic.com Under Neurological Therapies, click on: Intrathecal Baclofen Therapy for Severe Spasticity At the right side of the webpage, click on: